Apparatus and methods for monitoring transfusion of blood

ABSTRACT

Apparatus and methods are described for ensuring that blood transfused into a patient is the correct blood for that patient, is transfused in the correct manner and that a complete audit trail is created that will allow later tracing of blood from donation through to ultimate transfusion.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 11/061,899 filed Feb. 18, 2005, which is acontinuation-in-part of and claims priority to U.S. patent applicationSer. No. 10/783,438 filed Feb. 19, 2004, now U.S. Pat. No. 6,983,884,issued Jan. 10, 2006, which applications and patents are incorporated byreference herein in their entirety.

BACKGROUND OF THE INVENTION

1. Technical Field of the Invention

The present invention relates generally to apparatus and methods formonitoring the handling, transportation, and transfusion of blood and/orblood products. Apparatus and methods presented herein employelectronically readable indicia to confirm the identity of patients,blood units, and caregivers every time a blood unit is handled. Thepresent invention further relates to the collection, storage, andcommunication of information relevant to transfusions such that completeaudit trails are recorded and guidance to the caregiver is provided inorder to ensure that all required procedures are executed properly.

2. Description of the Related Art

Transfusion of blood is a high-risk procedure. A patient may be killedor seriously harmed if the wrong type of blood or blood product istransfused, may be infected by blood bourn pathogens or may haveunexpected reactions to blood products. For these reasons, considerablecare is taken in the collection, processing, packaging, labeling andtransport of blood units. Blood collection and supply agencies (CanadianBlood Services (Canada), American Red Cross, America's Blood Centers(USA), National Blood Services (UK)) keep detailed records of donations,processing, packaging and transport of blood products so that any singleblood product can be traced back to an individual donor. Using thisinformation, it should be possible to find and inform all patients whomay have been exposed to blood from a particular donor that they mightbe at risk should a problem arise.

Blood transfusions are usually performed at hospitals. Hospital bloodbanks receive blood from the blood supply agency, perform any tests theymay require to assure the type and quality of the blood and place theblood into the blood bank stock.

The first step in the transfusion process is testing of the patient'sblood. This requires that a blood sample be drawn from the patient,correctly labeled with the patient's identification, and sent to theblood laboratory. The laboratory tests the patient's blood to determinethe correct blood type for the patient, and any special requirements thepatient may have. Once these factors are known, a suitable blood unit isretrieved from the blood bank stock and is labeled as suitable for theparticular patient. The designated blood unit is placed into a storagelocation until it is needed. The blood laboratory keeps detailed recordsof the testing of the blood unit and the patient's blood.

The detailed records of the patient's blood test results, blood type andrequirements is usually stored in a blood bank computer system (McKessonCorporation, www.mckesson.com, Misys, www.misys.com, Meditech,www.meditech.com and many others). This information, along with ahistory of previous blood transfusions, may be used to quickly allocateadditional blood units for the patient without the need to repeat theoriginal blood test, in a process call ‘electronic issue’ of bloodunits.

When the patient requires blood for transfusion, someone is sent to theblood bank to collect the prepared blood unit. They are expected toensure that they have collected the correct blood unit, and to recordthe time that the blood unit was retrieved. Accepted practice requiresthat blood that has remained outside of refrigeration for more than 30minutes should not be transfused. It is the responsibility of the personcollecting the blood from the blood bank to ensure that it is promptlydelivered.

The transfusion step is tightly controlled. The caregiver administeringthe blood is required to follow a strict procedure that includes carefulchecking to ensure that the blood is labeled for the patient to betransfused, that the label is on the right blood unit, and that the unitis the correct blood type, meets any special requirements for thepatient and has not expired. All of these checks are recorded to ensurethat a full audit trail exists for the transfusion event, and to confirmthat the correct checks were performed. This audit trail is the onlymeans to link the original blood donation to the patient.

During the transfusion process, the caregiver is expected to record thepatient's vital signs on a regular basis, and to record any reactions tothe blood that the patient might experience. Reporting such reactions tothe blood bank, and possibly on to the blood collection agency, may beappropriate to ensure that other patients are not similarly affected.

These procedures are fraught with latent errors. The original bloodsample for matching the blood may be collected from the wrong patient,or may be mislabeled. The person picking up the blood unit from theblood bank may pick up the wrong blood unit. It may take too long tocarry the blood unit to the patient, so that the blood has exceeded 30minutes outside of refrigeration. There are even more risks during thetransfusion process. The patient may not be wearing a suitable wristbandproviding positive patient identification, making it impossible for thecaregiver to confirm that the blood unit is intended for that patient.The caregiver may misread the blood unit's unique identification number(which can be more 15 characters in length) when comparing it to thecompatibility label. Errors may be made in transcribing the patientinformation or blood unit number into the patient record. The standardprocedures for transfusion involve many steps that may be forgotten ornot properly completed, particularly if the caregiver is expected torecall the procedure from memory.

Despite the best efforts of blood supply agencies, it is not uncommonfor the trail of a blood unit to be lost as soon as it is delivered to ahospital blood bank. There may be records within the blood bank showingwhich patient a blood unit was prepared and tested for, but once again,the blood bank usually loses track of the blood unit once it leave theblood bank. Most blood banks assume that any blood units not returned tothe blood bank have been transfused. Blood supply agencies assume thatany blood delivered to a hospital blood bank was either transfused orwasted.

Although ‘electronic issue’ capability is common in blood bank softwaresystems, the full potential of electronic issue is rarely used. Byallocating blood for patients in advance, a large amount of blood isreserved, and hence unavailable for other patients. Electronic issue isintended to mitigate this by allowing blood to be allocated on a ‘justin time’ basis, however, as the blood units must be labeled for eachpatient, this is still done in the blood bank, meaning that evenelectronic issue must be done somewhat in advance of need so that thereis time to collect the blood from the blood bank and transport it to thepatient.

There are products that attempt to ensure that blood samples drawn froma patient for testing are correctly labeled. (e.g., Safe Track, DataLogInternational Ltd., www.dataloguk.com, BDID, Becton Dickinson Ltd,www.bd.com, McKesson Corporation, www.mckesson.com) These systems do agood job of making sure that the label applied to the blood samplecollected from the patient match the information on the patient'swristband, but do not offer any improvement in the completion of theaudit trail for the complete transfusion process.

There have also been attempts to improve the monitoring of the movementof blood units from place to place, to ensure that the blood iscorrectly stored, that all movements are recorded and that the blooddoes is not outside of refrigeration for more than the allowed time.(e.g., Blood Track, DataLog International Ltd., www.dataloguk.com).These systems provide valuable audit information for movements from onestorage location to another, but lose track of the blood unit in thecritical last step, when the blood unit is removed for transfusion. Inaddition, the systems rely on users to scan various barcodes in thecorrect order to ensure that the movement of the blood units iscorrectly recorded.

There have also been attempts to improve the transfusion process itself.There are products that use barcode scanners to compare bar-codedinformation on the patient's wristband, the compatibility label and theblood unit to ensure a correct match. (e.g., Safe Track, DataLogInternational Ltd, www.dataloguk.com, Itrac, Immucor, www.immucor.com).These products do provide a means for improving the safety of thetransfusion step, but do not return information to the blood bank toconfirm the completion of the transfusion or report reactions. They alsofail to provide a means to ensure that the blood unit to be transfusedhas been stored and transported correctly and within the acceptable timelimits. Thus, there remains a need in the art for improved apparatus andmethods for ensuring reliable transfusion of blood and/or blood productsinto a specified patient.

SUMMARY OF THE INVENTION

The present invention fulfills these and related needs by providingapparatus and method for collecting and storing information relevant tothe blood transfusion process for a patient, including information aboutthe steps of collecting the blood sample, labelling the blood unit,collecting and transporting the blood unit, transfusing the blood unit,completion of the transfusion, and recording of any reactions that mayhave occurred. Within certain embodiments, the collected information istransmitted to a computer database so that a complete record oftransfusion events can be created and maintained.

Thus, the present invention provides means for ensuring that a patientis correctly identified and that a blood sample collected from thepatient is properly labelled. In another aspect, the invention ensuresthat a blood unit collected from a blood bank is associated with theintended patient and that the time elapsed between removal of the bloodunit from refrigeration and transfusion or subsequent storage isproperly recorded. In one embodiment of the invention, these recordingsteps are automatically performed with a minimum of actions required onthe part of the person collecting the blood.

Other embodiments of the present invention provide means for comparingthe information on a patient wristband and a compatibility label, andfurther comparing the information on the compatibility label withinformation on a blood unit to ensure a correct match between thepatient, the compatibility label, and the blood unit. Within certainaspects, the invention also includes a means for recording the patient'svital signs, and for recording any adverse reactions the patient mayhave to the blood transfusion.

Further the invention provides means for reliably transmittinginformation to the computer database either through a computer networkor without use of a computer network.

In addition, the invention provides means for presenting step-by-stepinstructions and reminders to the caregiver to ensure that all thecritical steps of the transfusion process are completed in the rightway.

The invention also provides a means to safely provide remote electronicissue of blood units for designated patients, reducing the amount ofblood inventory required by the blood bank.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, features and advantages of the presentinvention will become apparent upon reference to the following detaileddescription of the exemplary embodiment presented herein and to thedrawings wherein:

FIG. 1 illustrates a flowchart for transfusing blood products to apatient.

FIG. 2 is a schematic diagram of one possible apparatus for managing thesample collection, blood unit requesting and transfusion steps of FIG.1.

FIG. 3 illustrates a flowchart for the sample collection step of FIG. 1.

FIG. 4 illustrates a flowchart for the sample testing and blood unitallocation step of FIG. 1.

FIG. 5 is a flowchart for the blood unit requesting step of FIG. 1.

FIG. 6 is a schematic diagram of one possible apparatus for managing theblood unit transportation step of FIG. 1, in accordance with the presentinvention.

FIG. 7A-7D are flowcharts for the blood unit transportation step of FIG.1 using the apparatus of FIG. 6 (FIG. 7A) and for returning blood tostorage if it is not transfused, using the apparatus of FIG. 6 (FIG.7B).

FIGS. 8A-8C are flowcharts for the transfusion step of FIG. 1, showingthe steps for beginning a transfusion (FIG. 8A), for the transfusionstep of FIG. 1, showing the steps for recording observations orreactions (FIG. 8B), and for the transfusion step of FIG. 1, showing thesteps for completing a transfusion (FIG. 8C).

FIG. 9 is a flowchart for the remote electronic issue of blood using theapparatus of FIG. 6.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates one possible method for transfusing blood or a bloodproduct into a patient, while storing transfusion information intotransfusion database 10, in accordance with the invention. Thetransfusion method is best described in five steps, each of which isexplained in more detail below.

The first step in the transfusion method is to collect a blood samplefrom the patient 12. This sample is tested to determine what type ofblood is required for the patient. When the determination is complete,one or more blood units are allocated for the patient 14.

When a patient is determined to need a blood transfusion, a request ismade for the blood unit or units allocated to the patient 16. Therequested blood unit is transported to the patient's location 18, whereit is transfused 20.

At each step in the process, certain information is recorded intransfusion database 10 so that a complete record of the transfusionevent is available for review.

FIG. 2 illustrates apparatus suitable for implementing the samplecollection 12, Requesting 16 and transfusion 20 steps of the methodaccording to the invention. The apparatus includes several componentsthat are used in conjunction to execute the steps.

Each caregiver involved in the transfusion process has an identity means110 which includes electronically readable caregiver code 112. Caregivercode 112 may be a linear or two-dimensional barcode using any one ofmany common barcode formats, such as code39, code128, Interleave 2 of 5,PDF 417, Matrix code, or others. Caregiver code 112 may also be anyother type of electronically readable code means such as a RadioFrequency Identification (RFID) tag. Caregiver identity means 110 may bean employee identification card or similar item, in which caregiver code112 is embedded, or to which caregiver code 112 is applied. In theexemplary embodiment presented herein, caregiver code 112 is a barcodeor RFID label encoded with a unique number or letter combination, whichis applied to the caregivers' employee identification.

Each patient to be transfused wears a patient identification wristband114 which includes electronically readable patient code 116. Patientcode 116 may be a linear or two-dimensional barcode using any one ofmany common barcode formats, such as code39, code128, Interleave 2 of 5,PDF 417, Matrix code, or others. Patient code 116 may also be any othertype of electronically readable code means such as a Radio FrequencyIdentification (RFID) tag. In the exemplary embodiment presented herein,patient code 116 is a PDF-417 barcode or and RFID tag, in which thepatient's identity number, surname, forename, date of birth and sex areencoded.

In the exemplary embodiment presented herein wristband 114 is either aPDC Smart CompuBand or PDC Smart ScanBand (Precision DynamicsCorporation, www.pdcorp.com). These wristbands incorporate RFID chipsand can be programmed and printed with any standard barcodes usingprinters like the Zebra Technologies R402 printer/programmer (ZebraTechnologies, www.zebra.com). Although one possible embodiment of theinvention uses RFID wristbands, an alternative embodiment useswristbands having printed barcodes and no RFID chips. Wristbands thatmay be printed with barcodes are available from many sources, includingthe Z-Band from Zebra technologies. The Z-Band and similar products canbe printed using commonly available thermal and thermal transfer labelprinters.

The apparatus according to the invention also includes a portablecomputer, preferably a Personal Digital Assistant (PDA) 118. PDA 118includes reader 120 which is able to read caregiver code 112 and patientcode 116. Reader 120 may be a barcode scanner, a barcode imager or anRFID reader. PDA 118 is also preferably equipped with a wireless networkmeans, a touch screen, communication means for communicating with aportable printer, and is suitable for cleaning and disinfection. In theexemplary embodiment presented herein, PDA 118 is a Symbol PPT2748, aSymbol SPT1746, a Symbol MC50, a Symbol MC3000 (Symbol Technologies Ltd,www.symbol.com), an HHP Dolphin, or an Intermec Model 700.

Included on PDA 118 is software to implement the sample collection 12,requesting 16 and transfusion 20 methods in accordance with theinvention, as hereinafter described.

The apparatus further includes portable printer means 124 which cancommunicate with PDA 118 such that PDA 118 can cause printer 124 toprint labels as required. In the exemplary embodiment presented herein,printer 124 is a Zebra QL-220 (Zebra Technologies, www.zebra.com)battery powered printer which may be connected to PDA 118 with a cable.

Referring to FIG. 3, software included on PDA 118 provides means forperforming the sample collection process 12. At each step in samplecollection process 12, the software causes PDA 118 to display messagesto the caregiver indicating the next step that the caregiver shouldperform. This forces the caregiver to follow a pre-defined procedurethat is the same each time sample collection process 12 is performed.This has the effect of allowing even inexperienced caregivers to performa complex task as if they have been highly trained.

In the first step of sample collection process 12, PDA 118 displays amessage asking the caregiver to read their caregiver code 112 (step 22).To do this, the caregiver uses reader 120 of PDA 118 and either scanscaregiver code 112 (if caregiver code 112 is a barcode) or brings reader120 within range of caregiver code 112 (if caregiver code 112 is an RFIDtag). PDA 118 displays caregiver code 112 so that the caregiver canverify it.

Next, PDA 118 displays a message requesting the caregiver to readpatient code 116 (step 24). Using reader 120 of PDA 118, the caregivereither scans patient code 116 (if patient code 116 is a barcode) orbrings reader 120 within range of patient code 116 (if patient code 116is an RFID tag). PDA 118 displays the patient identification informationencoded in patient code 116. In the exemplary embodiment presentedherein, this display includes the patient's identification number,surname, forename, date of birth and sex. PDA 118 displays a messageasking the caregiver to confirm that the patient information is correct.Caregivers are expected to ask the patient their name and date of birthto ensure that the displayed information is correct before proceedingwith sample collection.

If the caregiver is satisfied that the information read from wristband114 is correct, they press a button on PDA 118 to confirm that they havechecked the information.

PDA 118 now displays a selection of tests for the caregiver to requestfor the blood sample. The caregiver presses the appropriate buttons onPDA 118 to indicate the tests they wish to have performed (step 25). Insome situations, the tests required for a blood transfusion arepre-determined and PDA 118 will automatically assign the tests and moveto the next step.

PDA 118 then displays a button for printing. The caregiver connects PDA118 to printer 124 and presses the print button, which causes printer124 to produce sample label 122 (step 26). A timer within PDA 118prevents the caregiver from printing label 122 if more than a pre-settime (typically 15 to 30 seconds) has passed since patient code 116 wasread. This encourages the caregiver to print the sample label while atthe patient's bedside, rather than at a later time when there is somechance that the label may be mixed up with other labels or applied tothe wrong sample.

Sample label 122 shows the patient identification information read frompatient code 116, the type of test required on the sample, and mayinclude a barcode encoding all or some of this information. In theexemplary embodiment presented herein, label 122 includes a PDF-417two-dimensional barcode which encodes the patient's identificationnumber, surname, forename, date of birth and sex, as well as a coderepresenting the test required, caregiver code 112, the time and date,and a unique identifier for PDA 118.

The caregiver now collects the required blood sample, following standardblood sample collection techniques (Step 28). Once the sample iscollected into the collection container, label 122 is applied to thecontainer (step 30).

PDA 118 now displays a button which allows the caregiver to confirm thatthe sample collection is complete. At this point, PDA 118 transmits arecord to transfusion database 10, recording the collection of the bloodsample (step 32). There are two ways in which this information can betransmitted to transfusion database 10. In the exemplary embodimentpresented herein, PDA 118 incorporates a wireless network connection(which may be an IEEE 802.11b wireless network connection or othersimilar wireless network connection). If available, this wirelessnetwork connection is used by the software included on PDA 118 to insertthe sample collection record into transfusion database 10.

In an alternative embodiment, PDA 118 is not equipped with a wirelessnetwork connection, or there is no wireless network available at thelocation where the blood sample is collected. In this case, the softwareon PDA 118 causes a second copy of label 122 to be printed by printer124. This second label, which in this embodiment includes a PDF-417two-dimensional barcode as described above, is taken to a computerconnected to transfusion database 10. This computer is equipped with abarcode reader capable of reading the PDF-417 barcode and inserting theinformation read into transfusion database 10.

Once the blood sample is collected and labelled, it is transported tothe blood bank laboratory for testing (step 34).

FIG. 4 illustrates the procedures followed in the blood bank laboratoryin preparation for a blood transfusion (step 14, FIG. 1). The exactprocedure followed by a specific laboratory may vary, so the followingprocedure should be taken as one possible example only.

Blood units collected by a blood collection agency are received by theblood bank (step 40). The unique identification, type and otherinformation about each blood unit are recorded.

Blood bank laboratories may do their own tests on received blood toconfirm the type of blood or to ascertain other special characteristicsof the blood (step 42). Once these tests are completed, the blood unitsare placed into storage within the blood bank (step 44), where theyawait assignment to a particular patient.

When the blood bank laboratory receives a blood sample collected for apatient (step 46), it is tested to determine the specific requirementsfor the patient (step 50). These tests will determine the patient'sblood type (A, B, O) and Rhesus Factor and determine if there are anyother particular requirements for the patient, such as antibodynegative, irradiated, or CMV Negative blood.

Once the test results are known, an appropriate blood unit for thepatient is selected from the stored blood units (step 50).

The unique identification number of the selected blood unit and thepatient identification as determined from the blood sample collectedfrom the patient are printed on a compatibility label (step 52). Inaccordance with the invention, this label also includes anelectronically readable compatibility code, which may be a linear ortwo-dimensional barcode or other electronically readable code means suchas a Radio Frequency Identification (RFID) tag. Encoded in the barcodeor RFID tag are the patient identification and unique identificationnumber of the blood unit. Standard blood transfusion practice dictatesthat there be at least three separate items of patient identificationincluded in the compatibility information, such as the patient IDnumber, surname and date of birth.

The printed compatibility label is applied to the selected blood bag(step 54), after which the labelled blood bag is placed into anappropriate storage location for pickup when required (step 56). Whenthe blood unit is placed into the storage location for pickup, recordsare inserted into transfusion database 10. This record includes the timeand date, the unique identification number of the selected blood unit,the patient's identification, and may include additional informationsuch as the sample number assigned to the blood sample drawn from thepatient, the results of the tests done in the blood bank laboratory, theblood type selected and the specific characteristics of the blood unitassigned.

FIG. 5 illustrates the process for requesting a blood unit for aparticular patient from the blood bank (FIG. 1 step 16). This procedureuses the apparatus illustrated in FIG. 2.

When a caregiver wants to obtain a blood unit for transfusion, they mustcreate a request document to positively identify the patient for whomthe blood is needed, so that the person collecting the blood can be sureto collect the correct blood unit for the patient.

In the first step of blood unit requesting process (FIG. 1 step 14), PDA118 displays a message asking the caregiver to read their caregiver code112 (step 100). To do this, the caregiver uses reader 120 of PDA 118 andeither scans caregiver code 112 (if caregiver code 112 is a barcode) orbrings reader 120 within range of caregiver code 112 (if caregiver code112 is an RFID tag). PDA 118 displays caregiver code 112 so that thecaregiver can verify it.

Next, PDA 118 displays a message requesting the caregiver to readpatient code 116 (step 102). Using reader 120 of PDA 118, the caregivereither scans patient code 116 (if patient code 116 is a barcode) orbrings reader 120 within range of patient code 116 (if patient code 116is an RFID tag). PDA 118 displays the patient identification informationencoded in patient code 116. In the exemplary embodiment presentedherein, this display includes the patient's identification number,surname, forename, date of birth and sex. PDA 118 displays a messageasking the caregiver to confirm that the patient information is correct.Caregivers are expected to ask the patient their name and date of birthto ensure that the displayed information is correct before proceedingwith sample collection.

If the caregiver is satisfied that the information read from wristband114 is correct, they press a button on PDA 118 to confirm that they havechecked the information.

PDA 118 now displays a selection of blood products that a caregivermight require for the patient. This is most commonly Red Cells, but maybe Platelets, Flash Frozen Plasma, or other blood products. Thecaregiver presses the appropriate buttons on PDA 118 to indicate theblood product they require (step 104). In some situations, the systemmay be used for ordering only one type of blood product, in which casePDA 118 will automatically assign the product type and move to the nextstep.

PDA 118 then displays a button for printing. The caregiver connects PDA118 to printer 124 and presses the print button, which causes printer124 to produce request slip 122 (step 106).

Request slip 122 shows the patient identification information read frompatient code 116, the type of blood product required and may include abarcode encoding all or some of this information. In the exemplaryembodiment presented herein, request slip 122 includes a PDF-417two-dimensional barcode which encodes the patient's identificationnumber, surname, forename, date of birth and sex, as well as a coderepresenting the blood product required, required, caregiver code 112,the time and date, and a unique identifier for PDA 118.

The request slip printed in step 106 is given to a person responsiblefor collecting the patient's blood from the blood bank refrigerator.

FIG. 6 illustrates apparatus suitable for implementing thetransportation of allocated blood to the patient (FIG. 1 step 18).

Blood products assigned to a particular patient are stored inrefrigerator 70, which is usually in a location accessible to thosecharged with collecting blood for patients. Refrigerator 70 is equippedwith electronic lock 68, which in turn is connected to computer 66, suchthat software installed on computer 68 can lock and unlock refrigerator70.

Also connected to computer 66 is reader 64, which may be a barcodescanner or RFID reader. Computer 66 is also connected to speaker 74, andtransfusion database 10. Transfusion database 10 may be on a hard diskdrive installed within computer 66, or may be on a data storage deviceconnected to computer 66 via computer network connection 72 asillustrated in FIG. 6.

Computer 66 is further connected to touch screen 62 that provides avisual display and a touch operated user interface for operating thesoftware operating on computer 66.

In many hospitals where transfusions are performed, there are severalrefrigerators where blood designated for a particular patient may bestored. Blood assigned for a particular patient at the blood bank may bemoved from the blood bank refrigerator to another refrigerator closer tothe patient before it is finally collected for transfusion. Bloodremoved from the refrigerator for transfusion may not be used and willbe returned for use at a later time. In each case, it is important thatthe blood not be out of refrigeration for longer than an acceptabletime, and that any blood that has been out of refrigeration for too longnot be used.

For these reasons, the apparatus illustrated in FIG. 6 should normallybe installed at every location where blood it to be stored, eventemporarily. Each such installation will be connected to transfusiondatabase 10 so that data is shared among all instances of the apparatus.

FIG. 7A illustrates how the apparatus of FIG. 6 is used when collectingblood from a refrigerator for transfusion.

In one embodiment of the invention, reader 64 of FIG. 6 is a barcodescanner capable of reading both linear and two-dimensional barcodes. Inan alternative embodiment, reader 64 is an RFID reader. In the lattercase, the receiving antennas of RFID reader 64 are located both insiderefrigerator 70 and near the door of refrigerator 70, and are disposedso that any RFID tags located inside refrigerator 70 or near the outsideof refrigerator 70 may be read. Operation of the two differentembodiments of the invention will be described separately.

In the first embodiment of the invention, referring to FIG. 7A, thecaregiver collecting a blood unit identifies themselves by scanning thecaregiver code 112 on their caregiver identification 110, using reader64, which in this embodiment is a barcode reader (step 80). Softwarelocated on computer 66 determines if the caregiver identified bycaregiver code 112 is authorized to collect blood units, and if so,displays two buttons on touch screen 62. The caregiver touches theappropriate button to indicate that they intend to remove blood from therefrigerator (step 81).

The software on computer 66 uses speaker 74 and the display of touchscreen 62 to ask the caregiver to select the blood unit they wish toremove, and unlocks lock 68 so that the caregiver can open refrigerator70. The caregiver selects the blood upon labelled with a compatibilitylabel matching the patient for whom they are collecting the blood. Thecaregiver then closes refrigerator 70 and reads a barcode on the bloodunit that uniquely identifies the blood unit, or the compatibility labelon the blood unit (step 84), using reader 64.

The software on computer 66 now uses touch screen 62 uses speaker 74 torequest the caregiver to read the request slip printed when blood wasrequested for the patient (FIG. 1 step 16). The caregiver uses reader 64to read the two-dimensional barcode on the request slip (step 86). Thesoftware on computer 66 retrieves records from transfusion database 10to determine if the blood is still useable, and if so, retrieves recordsfrom transfusion database 10 to determine which patient the blood unitwas assigned to, and compares this information to that encoded on therequest slip. If the information matches and the blood unit is stilluseable (step 88), the software on computer 66 uses speaker 74 and touchscreen 62 to provide confirmation that the correct blood unit has beenselected (step 92). If the information does not match or the blood isnot useable in step 88, the software on computer 66 uses speaker 74 andtouch screen 62 to warn the caregiver that the wrong blood was selected,and instructs them to replace the blood unit into refrigerator 70 andselect the correct blood unit (step 90).

As soon as the information is checked in step 88, a record of thetransaction is written into transfusion database 10. Recording errorsmade by the caregiver assists in corrective training and resolution ofthe sources of error.

Once the caregiver has selected the correct blood unit and verified it,the software on computer 66 engages lock 68 on refrigerator 70 andreturns to a state in which caregiver identification codes may be readto start the process again.

The caregiver may now transport the blood unit either to the patient fortransfusion, or to another refrigerator for further storage prior totransfusion (step 94).

Should the blood unit need to return to storage in the same or anotherrefrigerator 70, the process illustrated in FIG. 7B is followed.

First, the caregiver returning a blood unit identifies themselves byscanning the caregiver code 112 on their caregiver identification 110,using reader 64, which in this embodiment is a barcode reader (step150). Software located on computer 66 determines if the caregiveridentified by caregiver code 112 is authorized to return blood units,and if so, displays two buttons on touch screen 62. The caregivertouches the appropriate button to indicate that they intend to returnblood to refrigerator 70 (step 152).

The software on computer 66 uses speaker 74 and the display of touchscreen 62 to ask the caregiver to read the barcode on the blood unitthat uniquely identifies the blood unit, or the compatibility label onthe blood unit (step 154), using reader 64. Computer 66 unlocks lock 68so that the caregiver can place the blood unit into refrigerator 70.

The software on computer 66 retrieves records from transfusion database10 to determine when the blood unit was removed from refrigeration (step156). It then calculates the time that the blood unit has been outsideof refrigeration and compares the calculated time with the pre-setallowable time limits (step 160). If the blood unit has not been outsideof refrigeration for more than the allotted time, the software oncomputer 66 uses speaker 74 and touch screen 62 to give a confirmationmessage to the caregiver (step 164). If the blood unit has been outsideof refrigeration for longer than the allotted time, the software oncomputer 66 uses speaker 74 and touch screen 62 to give a warningmessage to the caregiver (step 162).

As soon as the information is checked in step 160, a record of thetransaction is written into transfusion database 10. If the blood unithas exceeded its allowable time outside of refrigeration, the record ismarks the blood unit as unusable. The software on computer 66 thenengages lock 68 on refrigerator 70 and returns to a state in whichcaregiver identification codes may be read to start the process again.

In the second exemplary embodiment presented herein of the invention,reader 64 is an RFID reader, and the compatibility label on the bloodunit includes an RFID tag, as does the request slip prepared in theblood requesting procedure (FIG. 1, step 18).

As illustrated in FIG. 7C, the procedure for removing a blood unit fromrefrigerator 70 in the alternative embodiment is somewhat different frompreviously described.

First, reader 64 reads caregiver code 112 located on the caregiver'sidentification 110 as soon as the caregiver's identification 110 iswithin range of reader 64 (step 170). As the antenna for RFID reader 64is disposed to read RFID tags near refrigerator 70, this alerts thesoftware located on computer 66 that a caregiver many want to removeblood from refrigerator 70. The software on computer 66 then instructsreader 66 to read the RFID tags on every blood unit inside refrigerator70 in order to establish an inventory of all blood units currentlyinside refrigerator 70 (step 172). Once this inventory is complete,computer 66 disengages lock 68 so that the caregiver may select a bloodunit for removal (step 174). The software on computer 66 then instructsreader 66 to read the RFID tags on every blood unit inside refrigerator70 in order to establish an inventory of all blood units remaininginside refrigerator 70 (step 176). The inventory from step 176 iscompared to the inventory from step 172 to determine which blood unitwas removed by the caregiver. As soon as the identity of the removedblood unit is established, the software on computer 66 retrieves recordsfrom transfusion database 10 to determine the identity of the patientfor which the blood bag is intended, and to determine if the blood unitis still useable.

The software on computer 66 then instructs reader 64 to read the RFIDtagged request slip prepared during the requesting step (FIG. 1, step16). The software compares the patient identification retrieved fromtransfusion database 10 and the data read from the request slip todetermine if the two match and if the blood unit is still useable (step180). If the information matches and the blood unit is still useable thesoftware on computer 66 uses speaker 74 and touch screen 62 to provideconfirmation that the correct blood unit has been selected (step 184).If the information does not match or the blood is not useable in step88, the software on computer 66 uses speaker 74 and touch screen 62 towarn the caregiver that the wrong blood was selected, and instructs themto replace the blood unit into refrigerator 70 and select the correctblood unit (step 182).

As soon as the information is checked in step 180, a record of thetransaction is written into transfusion database 10. Recording errorsmade by the caregiver assists in corrective training and resolution ofthe sources of error.

Once the caregiver has selected the correct blood unit and verified it,the software on computer 66 engages lock 68 on refrigerator 70 andreturns to a state in which caregiver identification codes may be readto start the process again.

The caregiver may now transport the blood unit either to the patient fortransfusion, or to another refrigerator for further storage prior totransfusion (step 186).

Should the blood unit need to return to storage in the same or anotherrefrigerator 70, the process illustrated in FIG. 7D is followed in thecase of the alternative embodiment.

First, reader 64 reads caregiver code 112 located on the caregiver'sidentification 110 as soon as the caregiver's identification 110 iswithin range of reader 64 (step 190). As the antenna for RFID reader 64is disposed to read RFID tags near refrigerator 70, this alerts thesoftware located on computer 66 that a caregiver many want to returnblood to refrigerator 70. The software on computer 66 then instructsreader 66 to read the RFID tags on every blood unit inside refrigerator70 in order to establish an inventory of all blood units currentlyinside refrigerator 70 (step 192). Once this inventory is complete,computer 66 disengages lock 68 so that the caregiver may put the bloodunit back inside refrigerator 70 (step 194). The software on computer 66then instructs reader 66 to read the RFID tags on every blood unitinside refrigerator 70 in order to establish an inventory of all bloodunits now inside refrigerator 70 (step 196). The inventory from step 196is compared to the inventory from step 192 to determine which blood unitwas added by the caregiver.

As soon as the identity of the removed blood unit is established, thesoftware on computer 66 retrieves records from transfusion database 10to determine when the blood unit was removed from refrigeration (step198). It then calculates the time that the blood unit has been outsideof refrigeration and compares the calculated time with the pre-setallowable time limits (step 200). If the blood unit has not been outsideof refrigeration for more than the allotted time, the software oncomputer 66 uses speaker 74 and touch screen 62 to give a confirmationmessage to the caregiver (step 202). If the blood unit has been outsideof refrigeration for longer than the allotted time, the software oncomputer 66 uses speaker 74 and touch screen 62 to give a warningmessage to the caregiver (step 204).

As soon as the information is checked in step 200, a record of thetransaction is written into transfusion database 10. If the blood unithas exceeded its allowable time outside of refrigeration, the record ismarks the blood unit as unusable. The software on computer 66 thenengages lock 68 on refrigerator 70 and returns to a state in whichcaregiver identification codes may be read to start the process again.

It can be seen from the description for the two embodiments of theapparatus illustrated in FIG. 6, that the embodiment in which reader 64is an RFID reader provides a much simpler set of actions by thecaregiver. The RFID embodiment of the invention requires few specificactions on the part of the caregiver to ensure that the blood units areproperly tracked and checked.

FIG. 8A illustrates the procedure for transfusing blood into a patient,using the apparatus depicted in FIG. 2.

Software included on PDA 118 provides means for performing the bloodtransfusion process (FIG. 1, step 20). At each step in the transfusionprocess, the software causes PDA 118 to display messages to thecaregiver indicating the next step that the caregiver should perform.This has the effect of forcing the caregiver to follow a pre-definedprocedure that is the same each time blood transfusion process 20 isperformed. This has the effect of allowing even inexperienced caregiversto perform the critical transfusion task as if they have been highlytrained.

In the first step of sample transfusion process 20, PDA 118 displays amessage asking the caregiver to read their caregiver code 112 (step130). To do this, the caregiver uses reader 120 of PDA 118 and eitherscans caregiver code 112 (if caregiver code 112 is a barcode) or bringsreader 120 within range of caregiver code 112 (if caregiver code 112 isan RFID tag). PDA 118 displays caregiver code 112 so that the caregivercan verify it.

Next, PDA 118 displays a message requesting the caregiver to readpatient code 116 (step 132). Using reader 120 of PDA 118, the caregivereither scans patient code 116 (if patient code 116 is a barcode) orbrings reader 120 within range of patient code 116 (if patient code 116is an RFID tag). PDA 118 displays the patient identification informationencoded in patient code 116. In the exemplary embodiment presentedherein, this display includes the patient's identification number,surname, forename, date of birth and sex. PDA 118 displays a messageasking the caregiver to confirm that the patient information is correct.Caregivers are expected to ask the patient their name and date of birthto ensure that the displayed information is correct before proceedingwith transfusion.

If the caregiver is satisfied that the information read from wristband114 is correct, they press a button on PDA 118 to confirm that they havechecked the information.

PDA 118 now displays a message asking the caregiver to read thecompatibility label on the blood unit (step 134). Once again, thecaregiver uses reader 120 of PDA 118 and either scans the compatibilitylabel (if the compatibility label includes a barcode) or brings reader120 within range of the compatibility label (if the compatibility labelincludes an RFID tag). PDA 118 displays the information encoded on thecompatibility label along with the patient information already read, sothat that caregiver can compare the patient information from bothsources. If the information appears to be the same, the caregiverpresses a button on PDA 118 to confirm that they have checked theinformation. This ensures that the right blood unit has been selectedfor the patient.

Before proceeding to the next step in the transfusion process, thesoftware on PDA 118 compares the patient information read from patientcode 116 on wristband 114 with the patient information read from thecompatibility label (step 136). If the information does not match, PDA118 displays a warning message and emits a warning sound (step 138). Arecord is inserted into transfusion database 10 that includes theinformation read from patient wristband 114 and the compatibility labeland recording that the wrong blood unit was selected for the patient.The program on PDA 118 will not permit the caregiver to continue withthe transfusion steps if the information does not match.

If the information read from patient code 116 and the compatibilitylabel on the blood unit match, the software on PDA 118 displays amessage asking the caregiver to read the blood unit label (step 140).Once again, the caregiver uses reader 120 of PDA 118 and either scansthe blood unit label (if the blood unit label includes a barcode) orbrings reader 120 within range of the blood unit label (if the bloodunit label includes an RFID tag). PDA 118 displays the informationencoded on the blood unit label along with the patient blood unitinformation already read from the compatibility label, so that thatcaregiver can compare the blood unit identification from both sources.If the information appears to be the same, the caregiver presses abutton on PDA 118 to confirm that they have checked the information.This ensures that the compatibility label has been placed on the rightblood unit.

Before proceeding to the next step in the transfusion process, thesoftware on PDA 118 compares the blood unit information read from thecompatibility label with the blood unit information read from the bloodunit label (step 142). If the information does not match, PDA 118displays a warning message and emits a warning sound (step 144). Arecord is inserted into transfusion database 10 that includes theinformation read from blood unit and the compatibility label andrecording that the compatibility label was placed on the wrong bloodunit. The program on PDA 118 will not permit the caregiver to continuewith the transfusion steps if the information does not match.

Provided that the blood unit label and compatibility label match, thesoftware on PDA 118 displays a message asking the caregiver to enter thepatient's vital signs prior to starting the transfusion (step 146).These vital signs usually include the patient's blood pressure, pulseand temperature.

Once the vital signs are recorded, the software on PDA 118 displays amessage asking the caregiver to confirm that various pre-transfusionchecks have been completed (step 147). PDA 118 requires that thecaregiver press a button next to each of these reminders to confirm thatthese pre-transfusion checks have been completed.

PDA 118 now displays a button which allows the caregiver to confirm thatthe blood transfusion has started. At this point, PDA 118 transmits arecord to transfusion database 10, recording the start of thetransfusion. There are two ways in which this information can betransmitted to transfusion database 10. In the exemplary embodimentpresented herein, PDA 118 incorporates a wireless network connection(which may be an IEEE 802.11b wireless network connection or othersimilar wireless network connection). If available, this wirelessnetwork connection is used by the software included on PDA 118 to insertthe transfusion start record into transfusion database 10. Thetransfusion start record includes the patient identification informationread from patient code 116, the patient information and blood unitinformation read from the compatibility label, the blood unitinformation read from the blood unit label, caregiver code 112, the timeand ate and a unique identifier for PDA 118.

At this stage, PDA 118 also displays a button for printing. Thecaregiver connects PDA 118 to printer 124 and presses the print button,which causes printer 124 to produce patient record label 122 (step 148).Patient record label 122 shows the patient identification, caregivercode 112, the blood unit number and the time and date. Patient recordlabel 122 may also include a barcode encoding some or all of thisinformation. In the exemplary embodiment presented herein, the printedpatient record includes a PDF-417 two-dimensional barcode which encodesthe patient identification information read from patient code 116, thepatient information and blood unit information read from thecompatibility label, the blood unit information read from the blood unitlabel, caregiver code 112, the time and date and a unique identifier forPDA 118.

In an alternative embodiment, PDA 118 is not equipped with a wirelessnetwork connection, or there is no wireless network available at thelocation where the blood transfusion is started. In this case, thesoftware on PDA 118 causes a second copy of patient record label 122 tobe printed by printer 124. This second label, which in this embodimentincludes a PDF-417 two-dimensional barcode as described above, is takento a computer connected to transfusion database 10. This computer isequipped with a barcode reader capable of reading the PDF-417 barcodeand inserting the information read into transfusion database 10.

FIG. 8B illustrates the procedure for recording the patient's vitalsigns or any transfusion reactions that may occur while transfusingblood into a patient, using the apparatus depicted in FIG. 2. Acceptedpractice dictates that a patient's vital signs be recorded every 15minutes or so during a transfusion. It is also expected that anyreactions to the blood transfusion will be promptly recorded.

The software on PDA 118 includes means for recording the patient's vitalsigns and any reactions that might be noticed. In the first step of therecording process, PDA 118 displays a message asking the caregiver toread their caregiver code 112 (step 240). To do this, the caregiver usesreader 120 of PDA 118 and either scans caregiver code 112 (if caregivercode 112 is a barcode) or brings reader 120 within range of caregivercode 112 (if caregiver code 112 is an RFID tag). PDA 118 displayscaregiver code 112 so that the caregiver can verify it.

Next, PDA 118 displays a message requesting the caregiver to readpatient code 116 (step 242). Using reader 120 of PDA 118, the caregivereither scans patient code 116 (if patient code 116 is a barcode) orbrings reader 120 within range of patient code 116 (if patient code 116is an RFID tag). PDA 118 displays the patient identification informationencoded in patient code 116. In the exemplary embodiment presentedherein, this display includes the patient's identification number,surname, forename, date of birth and sex. PDA 118 displays a messageasking the caregiver to confirm that the patient information is correct.Caregivers are expected to ask the patient their name and date of birthto ensure that the displayed information is correct before proceedingwith the observation.

If the caregiver is satisfied that the information read from wristband114 is correct, they press a button on PDA 118 to confirm that they havechecked the information. PDA 118 then displays a message requesting thecaregiver to read the blood unit identification from the blood unitcurrently being transfused. This ensures that any observations orreactions are associated with the correct blood unit. The caregiver usesreader 120 of PDA 118 and either scans the blood unit label (if theblood unit label includes a barcode) or brings reader 120 within rangeof the blood unit label (if the blood unit label includes an RFID tag).PDA 118 displays the blood unit identification so that the caregiver canverify it.

If the caregiver is satisfied that the information read from the bloodunit label is correct, they press a button on PDA 118 to confirm thatthey have checked the information PDA 118 now provides a screen on whichthe caregiver may enter the patient's vital signs (step 244).

As soon as the vital signs are entered, PDA 118 transmits a record totransfusion database 10, recording the vital signs observations. In theexemplary embodiment presented herein, PDA 118 uses s a wireless networkconnection to insert the observation record into transfusion database10. The observation record includes the observations recorded, thepatient identification information read from patient code 116, the bloodunit information read from the blood unit label, caregiver code 112, thetime and date and a unique identifier for PDA 118.

Once the vital signs are entered, a message on PDA 118 asks thecaregiver to press a button if any reactions are noted. If the button ispressed (step 246), PDA 118 offers a list of common reactions from whichthe caregiver may choose, or a place into which the caregiver can enterspecific notes about reactions (step 248).

As soon as any reactions are noted, PDA 118 transmits a record totransfusion database 10, recording the reactions. In the exemplaryembodiment presented herein, PDA 118 uses s a wireless networkconnection to insert the reactions record into transfusion database 10.The reactions record includes the reactions recorded, the patientidentification information read from patient code 116, the blood unitinformation read from the blood unit label, caregiver code 112, the timeand date and a unique identifier for PDA 118.

At this stage, PDA 118 also displays a button for printing. Thecaregiver connects PDA 118 to printer 124 and presses the print button,which causes printer 124 to produce patient observation label 122 (step250). Patient observation label 122 shows the patient's vital signs,patient identification, caregiver code 112, the blood unit number, thetime and date and any reactions that were observed. Patient observationlabel 122 may also include a barcode encoding some or all of thisinformation. In the exemplary embodiment presented herein, the printedpatient record includes a PDF-417 two-dimensional barcode which encodesthe patient identification information read from patient code 116, theblood unit information read from the blood unit label, caregiver code112, the time and date, the patient's vital signs and any reactionsnoted, and a unique identifier for PDA 118.

In an alternative embodiment, PDA 118 is not equipped with a wirelessnetwork connection, or there is no wireless network available at thelocation where the observation is made. In this case, the software onPDA 118 causes a second copy of patient record label 122 to be printedby printer 124. This second label, which in this embodiment includes aPDF-417 two-dimensional barcode as described above, is taken to acomputer connected to transfusion database 10. This computer is equippedwith a barcode reader capable of reading the PDF-417 barcode andinserting the information read into transfusion database 10.

Figure illustrates the procedure for recording the end of thetransfusion process using the apparatus of FIG. 2.

In the first step of recording the end of a transfusion, PDA 118displays a message asking the caregiver to read their caregiver code 112(step 252). To do this, the caregiver uses reader 120 of PDA 118 andeither scans caregiver code 112 (if caregiver code 112 is a barcode) orbrings reader 120 within range of caregiver code 112 (if caregiver code112 is an RFID tag). PDA 118 displays caregiver code 112 so that thecaregiver can verify it.

Next, PDA 118 displays a message requesting the caregiver to readpatient code 116 (step 254). Using reader 120 of PDA 118, the caregivereither scans patient code 116 (if patient code 116 is a barcode) orbrings reader 120 within range of patient code 116 (if patient code 116is an RFID tag). PDA 118 displays the patient identification informationencoded in patient code 116. In the exemplary embodiment presentedherein, this display includes the patient's identification number,surname, forename, date of birth and sex. PDA 118 displays a messageasking the caregiver to confirm that the patient information is correct.Caregivers are expected to ask the patient their name and date of birthto ensure that the displayed information is correct before proceedingwith the end transfusion record.

If the caregiver is satisfied that the information read from wristband114 is correct, they press a button on PDA 118 to confirm that they havechecked the information. PDA 118 then displays a message requesting thecaregiver to read the blood unit identification from the blood unitcurrently being transfused (step 256). This ensures that the endtransfusion record and any observations or reactions are associated withthe correct blood unit. The caregiver uses reader 120 of PDA 118 andeither scans the blood unit label (if the blood unit label includes abarcode) or brings reader 120 within range of the blood unit label (ifthe blood unit label includes an RFID tag). PDA 118 displays the bloodunit identification so that the caregiver can verify it.

If the caregiver is satisfied that the information read from the bloodunit label is correct, they press a button on PDA 118 to confirm thatthey have checked the information PDA 118 now provides a screen on whichthe caregiver may enter the patient's vital signs (step 258).

As soon as the vital signs are entered, PDA 118 transmits a record totransfusion database 10, recording the vital signs observations. In theexemplary embodiment presented herein, PDA 118 uses a wireless networkconnection to insert the observation record into transfusion database10. The observation record includes the observations recorded, thepatient identification information read from patient code 116, the bloodunit information read from the blood unit label, caregiver code 112, thetime and date and a unique identifier for PDA 118.

Once the vital signs are entered, a message on PDA 118 asks thecaregiver to press a button if any reactions are noted. If the button ispressed (step 260), PDA 118 offers a list of common reactions from whichthe caregiver may choose, or a place into which the caregiver can enterspecific notes about reactions (step 262).

As soon as any reactions are noted, PDA 118 transmits a record totransfusion database 10, recording the reactions. In the exemplaryembodiment presented herein, PDA 118 uses a wireless network connectionto insert the reactions record into transfusion database 10. Thereactions record includes the reactions recorded, the patientidentification information read from patient code 116, the blood unitinformation read from the blood unit label, caregiver code 112, the timeand date and a unique identifier for PDA 118.

Whether or not reactions are noted, PDA 118 transmits a record totransfusion database 10, recording the completion of the transfusion. Inthe exemplary embodiment presented herein, PDA 118 uses a wirelessnetwork connection to insert the end transfusion record into transfusiondatabase 10. The end transfusion record includes a code to indicate thatthe transfusion is complete, the patient identification information readfrom patient code 116, the blood unit information read from the bloodunit label, caregiver code 112, the time and date and a uniqueidentifier for PDA 118.

At this stage, PDA 118 also displays a button for printing. Thecaregiver connects PDA 118 to printer 124 and presses the print button,which causes printer 124 to produce end transfusion label 122 (step264). End transfusion label 122 shows the patient's vital signs, patientidentification, caregiver code 112, the blood unit number, the time anddate any reactions that were observed and an indication that thetransfusion is complete. Patient observation label 122 may also includea barcode encoding some or all of this information. In the exemplaryembodiment presented herein, the printed patient record includes aPDF-417 two-dimensional barcode which encodes the patient identificationinformation read from patient code 116, the blood unit information readfrom the blood unit label, caregiver code 112, the time and date, thepatient's vital signs and any reactions noted, and a unique identifierfor PDA 118.

In an alternative embodiment, PDA 118 is not equipped with a wirelessnetwork connection, or there is no wireless network available at thelocation where the observation is made. In this case, the software onPDA 118 causes a second copy of patient record label 122 to be printedby printer 124. This second label, which in this embodiment includes aPDF-417 two-dimensional barcode as described above, is taken to acomputer connected to transfusion database 10. This computer is equippedwith a barcode reader capable of reading the PDF-417 barcode andinserting the information read into transfusion database 10.

FIG. 9 illustrates a means for improving the safety and efficiency ofelectronic issue of blood using the apparatus of FIG. 6.

In this embodiment of the invention, the caregiver collecting a bloodunit identifies themselves by scanning the caregiver code 112 on theircaregiver identification 110, using reader 64, which in this embodimentis a barcode reader (step 270). Software located on computer 66determines if the caregiver identified by caregiver code 112 isauthorized to collect blood units, and if so, displays two buttons ontouch screen 62. The caregiver touches the appropriate button toindicate that they intend to remove blood from the refrigerator (step272). This causes the display of touch screen 62 to offer the choice ofremoving a pre-allocated blood unit, or using electronic issue. Thecaregiver touches the electronic issue button on touch screen 62 (step274).

The software on computer 66 now uses speaker 74 and the display of touchscreen 62 to ask the caregiver read the request slip printed when bloodwas requested for the patient (FIG. 1 step 16). The caregiver usesreader 64 to read the two-dimensional barcode on the request slip (step276). The software on computer 66 sends a message to blood bank computersystem 278 asking if the patient identified by the caregiver is suitablefor electronic issue. Blood bank computer system 278 returns a messageindicating if the patient is eligible for electronic issue, and if so,what type of blood should be issued.

The software on computer 66 now determines if suitable blood for theidentified patient is available. It does this by checking to see if asuitable blood unit is recorded as having been placed in the currentstorage location (step 280). If no suitable blood is available, thesoftware on computer 66 uses speaker 74 and the display of touch screen62 to tell the caregiver that no blood is available (step 282) andrecords the attempted transaction in transfusion database 10. Ifsuitable blood is available, the software on computer 66 uses speaker 74and the display of touch screen 62 to tell the caregiver to select anappropriate blood unit from refrigerator 70.

The software on computer 66 now unlocks lock 68 on refrigerator 70. Inan alternative embodiment, refrigerator 70 is a multi-compartmentrefrigerator, wherein each compartment has a separate lock 68. In thisembodiment, only the compartment of refrigerator 70 which contains bloodof the right type for the patient identified is unlocked, therebypreventing access to blood of the wrong type for the patient.

The software on computer 66 uses speaker 74 and the display of touchscreen 62 to ask the caregiver to select the blood unit they wish toremove, and to scan a barcode on the blood unit that uniquely identifiesthe blood unit (step 284). The software on computer 66 then causescompatibility label 71 to be printed on printer 73. Now the software oncomputer 66 uses speaker 74 and the display of touch screen 62 to askthe caregiver to apply compatibility label 71 to the blood unit (step286), then scan both the barcode on the blood unit that uniqueidentifies the blood unit and compatibility label 71 (step 288).

If the barcode on the blood unit and the information in compatibilitylabel 71 match, and if both barcodes were scanned within a short period(five seconds in the exemplary embodiment presented herein), thesoftware on computer 66 uses the display of touch screen 62 to tell thecaregiver that the blood unit is safe to transport (step 294). If theinformation fails to match, the software on computer 66 uses speaker 74and the display of touch screen 62 to tell the caregiver that the bloodis incorrectly labelled and should not be used (step 292). In eithercase, a record of the transaction is stored in transfusion database 10.

Should the two barcodes not be scanned within the allowed time period,the software on computer 66 uses the display of touch screen 62 to tellthe caregiver to try scanning the labels again. The short time delaybetween the two scans ensures that label 71 is attached to the bloodunit and that label 71 and the blood unit are not being scannedseparately.

From the detailed description above, it can be seen that the inventionprovides means for recording every step in the transfusion process,including all movements of the blood unit prior to transfusion. Each ofthe steps is recorded in transfusion database 10. It will be obvious toone skilled in the art that data collected in this way can easily beread into a database program such as Microsoft Access (MicrosoftCorporation, www.microsoft.com) from which various reports can becreated. It is also possible, with the same database program, todetermine the complete history of any particular blood unit or bloodunits.

Furthermore, the exemplary embodiment presented herein of the invention(in which PDA 118 is wirelessly connected to transfusion database 10)provides a means for monitoring blood transfusion as they occur. Asevery step in the transfusion process is immediately recorded intransfusion database 10, it is a simple matter to determine which bloodunits are currently being transfused at any time.

Many different adaptations and variations of the subject invention arepossible without departing from the scope and spirit of the presentinvention, therefore, the present invention should be limited only bythe scope of the appended claims. For example the delivery of drugs topatients presents many of the same problems as those described hereinfor blood transfusion. It would be clear to one skilled in the art thata system similar to that described here could be used to control thecollection and administration of drugs to a patient.

1. An apparatus for implementing blood sample collection, blood unitrequesting, and blood unit transfusion into a patient, said apparatuscomprising: a caregiver identity means comprising an electronicallyreadable caregiver code; a patient identification wristband comprisingan electronically readable patient code; a portable computer comprisinga reader wherein said reader is capable of reading said caregiver codeand said patient code and software to implement the process of samplecollection wherein said process of sample collection comprises the stepof causing said portable computer to present messages to a caregiverthat indicate to said caregiver a predefined series of steps, presentedstep-by-step, to be performed by said caregiver in the sample collectionprocess and a portable printer wherein said portable printer is capableof communicating with said portable computer.
 2. The apparatus of claim1 wherein said caregiver identity means is an employee identificationcard and wherein said employee identification card comprises saidcaregiver code.
 3. The apparatus of claim 1 wherein said electronicallyreadable caregiver code includes multiple categories of data and isselected from the group consisting of a two-dimensional barcode, and aRadio Frequency Identification (RFID) tag.
 4. The apparatus of claim 1wherein said electronically readable patient code includes multiplecategories of data and is selected from the group consisting of atwo-dimensional barcode, and a Radio Frequency Identification (RFID)tag.
 5. The apparatus of claim 4 wherein said two-dimensional barcode isselected from the group consisting of PDF 417, Aztec code, and Matrixcode.
 6. The apparatus of claim 1 wherein said portable computer is aPersonal Digital Assistant (PDA) and wherein said reader is selectedfrom the group consisting of a barcode scanner, a barcode imager, and anRFID reader.
 7. The apparatus of claim 6 wherein said PDA comprises awireless network means for communicating with a wireless network, atouch screen, and a communication means for communicating with saidportable printer.
 8. The apparatus of claim 1 wherein said messages tothe caregiver comprise the following: a request to said caregiver toread a caregiver code; a request to said caregiver to read a patientcode; a request to said caregiver to verify the accuracy of displayedpatient identification information; a selection of tests for saidcaregiver to request for a blood sample; and a request to said caregiverto print a blood sample label.
 9. The apparatus of claim 8 wherein saidselection of tests are automatically assigned by said portable computer.10. The apparatus of claim 9 wherein said portable computer furthercomprises a timer wherein said timer prevents said caregiver fromprinting said blood sample label if more than a pre-set time has passedsince said patient code was read.
 11. The apparatus of claim 9 furthercomprising a request to said caregiver to verify that said blood samplecollection is complete, wherein the caregiver enters verification datain said portable computer.
 12. The apparatus of claim 9 wherein saidportable computer transmits a record to a transfusion database.
 13. Theapparatus of claim 12 wherein said information is transmitted to saidtransfusion database via a wireless network connection.
 14. Theapparatus of claim 13 wherein a barcode reader connected to a computerconnected to said transfusion database is capable of scanning saidsample collection label and writing said blood sample requestinformation into said transfusion database.
 15. An apparatus forimplementing blood sample collection, blood unit requesting, and bloodunit transfusion into a patient, said apparatus comprising: a caregiveridentity means comprising an electronically readable caregiver code; apatient identification wristband comprising an electronically readablepatient code; a portable computer comprising a reader wherein saidreader is capable of reading said caregiver code and said patient codeand software to implement the process of sample collection wherein saidprocess of sample collection comprises the step of causing said portablecomputer to display messages to a caregiver that indicate to saidcaregiver the next step in a predefined series of steps to be performedby said caregiver; a portable printer wherein said portable printer iscapable of communicating with said portable computer; and a lockablerefrigerated storage compartment for storing a blood unit, including acomputer and software installed on said computer, said software incombination with said computer capable of instructing said lockablerefrigerator to become locked or to become unlocked.
 16. The apparatusof according to claim 15 including recording means for recording themovement of a blood unit into and out of said refrigerated storagecompartment, said recording means comprising: a first Radio FrequencyIdentification (RFID) tag attached to a blood unit, wherein said RFIDtag encodes a blood unit identification code for said blood unit; asecond RFID tag for a user of said apparatus, wherein said second RFIDtag encodes a user identification code; an antenna disposed to read allRFID tags inside and in the vicinity of a refrigerated storagecompartment; a device for receiving data via said antenna from saidfirst RFID tag and said second RFID tag and sending said received datato a computer; and a computer for receiving data from said datareceiving device.
 17. An apparatus for implementing blood samplecollection, blood unit requesting, and blood unit transfusion into apatient, said apparatus comprising: an electronically readable caregivercode; an electronically readable patient wristband with anelectronically readable patient code; a first computer including anelectronic reader, wherein said reader is capable of reading saidcaregiver code and said patient code; software to implement to processof sample collection wherein said process of sample collection comprisesthe step of causing said first computer to display messages to acaregiver that indicate to said caregiver the next step in a predefinedseries of steps to be performed by said caregiver; a portable printercapable of communicating with said first computer; and a lockablerefrigerated storage compartment for storing a blood unit, including asecond computer and software installed on said second computer, saidsoftware in combination with said second computer capable of instructingsaid lockable refrigerator to become locked or to become unlocked. 18.The apparatus according to claim 17 including: a reader connected tosaid second computer; a speaker connected to said second computer; and atouch screen, wherein said touch screen provides a visual display and atouch operated user interface for operating said software installed onsaid second computer.
 19. The apparatus of claim 18 wherein saidsoftware installed on said second computer determines if the caregiveridentified by said caregiver code is authorized to collect blood unitsand wherein when said caregiver is authorized to collect blood units,two buttons are displayed on said touch screen wherein a first of saidtwo buttons indicates that caregiver is adding a blood product to saidrefrigerated storage compartment and wherein a second of said twobuttons indicates that a caregiver is removing a blood product from saidrefrigerated storage compartment.
 20. An apparatus for implementingblood sample collection, blood unit requesting, and blood unittransfusion into a patient, said apparatus comprising: an electronicallyreadable caregiver code; an electronically readable patient wristbandwith an electronically readable patient code; a first computer includingan electronic reader, said reader capable of reading said caregiver codeand said patient code; software to implement to process of samplecollection wherein said process of sample collection includes the stepof causing said first computer to display messages to a caregiver thatindicate to said caregiver the next step in a predefined series of stepsto be performed by said caregiver; a printer capable of communicatingwith said first computer; recording means for recording the movement ofa blood unit into and out of a refrigerated storage compartment, saidrecording means comprising a first Radio Frequency Identification (RFID)tag attached to a blood unit, wherein said RFID tag encodes a blood unitidentification code for said blood unit, a second RFID tag for a user ofsaid apparatus, wherein said second RFID tag encodes a useridentification code; an antenna disposed to read all RFID tags insideand in the vicinity of the refrigerated storage compartment; a devicefor receiving data via said antenna from said first RFID tag and saidsecond RFID tag and sending said received data to a computer; and asecond computer for receiving data from said data receiving device.